US10226458B2ActiveUtilityA1

Pharmaceutical compositions comprising sorbitan esters

84
Assignee: ALKERMES PHARMA IRELAND LTDPriority: Mar 18, 2011Filed: Dec 22, 2016Granted: Mar 12, 2019
Est. expiryMar 18, 2031(~4.7 yrs left)· nominal 20-yr term from priority
A61K 9/0019A61K 47/26A61K 31/551A61P 25/24A61P 25/18A61P 25/00A61K 31/5513A61K 31/496A61K 31/497A61K 31/4965A61K 9/10A61K 31/381A61K 2121/00A61K 47/30A61K 47/14A61K 45/00
84
PatentIndex Score
1
Cited by
206
References
21
Claims

Abstract

The present invention relates to a pharmaceutical composition comprising sorbitan esters of carboxylic acids that are useful for the delivery of anti-psychotic drugs.

Claims

exact text as granted — not AI-modified
The invention claimed is: 
     
       1. A method for treating schizophrenia, bipolar disorder, or depression in a subject in need thereof comprising administering to the subject an effective amount of a pharmaceutical composition comprising:
 (a) compound A-7: 
 
       
         
           
           
               
               
           
         
         (b) sorbitan laurate; 
         (c) polysorbate 20; and 
         (d) an aqueous vehicle, 
         wherein the composition forms an aqueous, flocculated, injectable suspension. 
       
     
     
       2. The method of  claim 1 , wherein depression is treated. 
     
     
       3. The method of  claim 1 , wherein bipolar disorder is treated. 
     
     
       4. The method of  claim 1 , wherein schizophrenia is treated. 
     
     
       5. The method of  claim 1 , wherein the ratio of components (b) to (c) is approximately 5 to 2, by weight. 
     
     
       6. The method of  claim 1 , comprising about 0.2- 1 weight percent sorbitan laurate. 
     
     
       7. The method of  claim 1 , comprising about 0.4- 0.7 weight percent sorbitan laurate. 
     
     
       8. The method of  claim 1 , comprising about 0.5 weight percent sorbitan laurate. 
     
     
       9. The method of  claim 1 , comprising about 0.05- 0.8 weight percent polysorbate 20. 
     
     
       10. The method of  claim 1 , comprising about 0.1- 0.3 weight percent polysorbate 20. 
     
     
       11. The method of  claim 1 , comprising about 0.2 weight percent polysorbate 20. 
     
     
       12. The method of  claim 1 , comprising approximately 15- 35 weight percent compound A-7. 
     
     
       13. The method of  claim 1 , comprising approximately 20- 30 weight percent compound A-7. 
     
     
       14. A method for treating schizophrenia, bipolar disorder, or depression in a subject in need thereof comprising administering to the subject an injectable pharmaceutical composition comprising:
 (a) 15-35 weight percent compound A-7: 
 
       
         
           
           
               
               
           
         
         (b) approximately 0.2-1 weight percent sorbitan laurate; 
         (c) approximately 0.05-0.8 weight percent polysorbate 20; and 
         (d) an aqueous carrier. 
       
     
     
       15. The method of  claim 14 , wherein schizophrenia is treated. 
     
     
       16. A method for treating schizophrenia, bipolar disorder, or depression in a subject in need thereof comprising administering to the subject an injectable composition comprising:
 (a) compound A-7: 
 
       
         
           
           
               
               
           
         
         (b) sorbitan laurate; 
         (c) polysorbate 20; and 
         (d) an aqueous vehicle. 
       
     
     
       17. The method of  claim 16 , wherein the composition further comprises a buffer. 
     
     
       18. The method of  claim 17 , wherein the buffer is a phosphate, citrate, tartrate or acetate buffer. 
     
     
       19. The method of  claim 16 , wherein schizophrenia is treated. 
     
     
       20. A method for treating schizophrenia, bipolar disorder, or depression in a subject in need thereof comprising administering to the subject a pharmaceutical composition comprising:
 (a) 24-30 weight percent compound A-7: 
 
       
         
           
           
               
               
           
         
         (b) 0.2-1 weight percent sorbitan laurate; 
         (c) 0.1-0.3 weight percent polysorbate 20; and 
         (d) an aqueous vehicle. 
       
     
     
       21. The method of  claim 20 , wherein schizophrenia is treated.

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